Review recommended dosing by indication, including dosage adjustments where appropriate, and additional considerations.
Opioid use warning
Convenient combination treatment taken once daily
Once-daily dosing with or without food as a single tablet
Schizophrenia in adults1
Bipolar I disorder in adults (manic or mixed episodes)1
Tablets not shown at actual size.
- The dosage of samidorphan is fixed at 10 mg across all dosage forms1
- The maximum recommended dosage is 20 mg/10 mg once daily1
- Do not divide tablets or combine strengths1
Additional dosage considerations
Dosage may be adjusted at weekly intervals of 5 mg (olanzapine component) depending upon clinical response and tolerability
- For bipolar I disorder monotherapy, dosage adjustments should occur at intervals of not less than 24 hours
No dosage adjustment is needed for hepatic impairment or patients with mild, moderate, or severe renal impairment1
- Not recommended for end-stage renal disease
Dosage recommendations in specific populations1
The recommended starting dosage is 5 mg/10 mg once daily in patients who have a higher risk of hypotensive reactions, are at risk of slower olanzapine metabolism, or may be more pharmacodynamically sensitive to olanzapine; if dose escalation is necessary, increase the dosage slowly in these patients.
Please see LYBALVI Prescribing Information for additional dosing details.
Opioid use warning
LYBALVI is contraindicated in patients using opioids (for example, codeine, oxycodone, tramadol, or morphine) or those undergoing acute opioid withdrawal
Precipitation of severe opioid withdrawal in patients who are physiologically dependent on opioids
Prior to initiating LYBALVI, there should be at least a 7-day opioid-free interval from last use of short‑acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids
- Explain the risks associated with precipitated withdrawal and the importance of giving an accurate account of last opioid use to patients and caregivers
Samidorphan, a component of LYBALVI, can precipitate severe opioid withdrawal in patients who are physiologically dependent on opioids
- Administration may result in withdrawal syndrome severe enough to require hospitalization
Vulnerability to life-threatening opioid overdose
Patients attempting to overcome LYBALVI’s opioid blockade with high or repeated doses of exogenous opioids could lead to life‑threatening or fatal opioid intoxication (eg, respiratory arrest, circulatory collapse)
- Inform patients of the potential consequences of trying to overcome the opioid blockade and the serious risks of taking opioids concurrently with LYBALVI or while transitioning off LYBALVI
Patients with a history of chronic opioid use prior to treatment with LYBALVI may have decreased tolerance to opioids if LYBALVI therapy is interrupted or discontinued
- Advise patients that this decreased tolerance may increase the risk of opioid overdose if opioids are resumed at previously tolerated dosages
In emergency situations, if a LYBALVI-treated patient requires opioid treatment as part of anesthesia or analgesia:
- Discontinue LYBALVI,
- Opioids should be administered by individual(s) trained in the use of anesthetic drugs and the management of the respiratory effects of opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation, and
- Appropriately trained personnel should continuously monitor the patient in a setting equipped and staffed for cardiopulmonary resuscitation
Please see LYBALVI Prescribing Information for additional details on LYBALVI use and opioids.
LYBALVI® Patient Counseling Tool
This resource is intended for use by healthcare providers to support counseling patients about opioid-related safety information for LYBALVI.
Please review the Medication Guide with your patients.
Reference: LYBALVI [prescribing information]. Waltham, MA: Alkermes, Inc.; 2021.